Quality Control Associate I

Updated: 5 months ago
Location: Fort Collins, COLORADO

Posting Details

Posting Detail Information

Working Title Quality Control Associate I
Position Location Fort Collins, CO
Research Professional Position No
Posting Number 201901152AP
Position Type Admin Professional/ Research Professional
Number of Vacancies
Work Hours/Week 40
Proposed Annual Salary Range 30,000-55,000
Desired Start Date
Position End Date (if temporary)
To ensure full consideration, applications must be received by 11:59pm (MT) on 01/05/2020
Description of Work Unit

BioMARC is a contract manufacturing organization (CMO) of FDA regulated products. It was created to fill an industry need for higher containment biologic manufacturing. BioMARC is a nonprofit CMO owned and operated by CSU, and was created to translate and produce biopharmaceutical products for non-clinical, clinical, and commercial use under Biosafety level 2, 3 and Select Agent biosecurity conditions. In addition to manufacturing and testing services, BioMARC offers product and process development services, which includes the creation of development programs focused on implementing cGMP regulations and scalability issues.

Position Summary

Under the supervision of Quality Control (QC) Manager/Supervisor, the QC Associate I is responsible for the implementation of policies and procedures to ensure that QC standards are met during production. It requires escalating levels of experience in executing complicated batch production records for the creation and/or processing of production materials. QC Associates must be able work within an FDA recognized Quality System (or similar) using Quality Assurance approved batch cards, SOPs, protocols and/or the like. Higher Education degree in microbiology, biotechnology, chemical/biomedical engineering, pharmacology, or related field is strongly suggested. Continuous self-directed training in the US Code of Federal Regulation fields of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and/or Quality Assurance/Control is highly suggested. Employees will physically perform complex laboratory techniques in rooms that require specialized manufacturing and biocontainment protective gowning and equipment. Entry into Biosafety level 3 laboratories is likely. Employees will think critically through instructions and make professional judgments with regard to compliance, quality and continuous improvement paradigms. Employees will investigate and report on incidents and provide intelligent corrective proposals. May provide support services to Method Development or Preclinical Production projects using similar techniques to above.

Required Job Qualifications

• Bachelor’s degree in the Sciences or a field related to the responsibilities of the assignment.
• OR Bachelor’s degree in an unrelated field plus 2 years of professional experience related to the specific assignment or 1 year experience in a contract manufacturing organization.

Preferred Job Qualifications

• Experience in an analytical, cell biology, or microbiology type laboratory. Examples of relevant experience includes but is not limited to: Plate-based assays such as ELISAs, Bradford, or BCA, qPCR, gel electrophoresis, Western Blot, cell/tissue culture, media preparation, bioburden testing, environmental monitoring.
• Experience in a contract manufacturing or other regulated environment.
• Has experience in US code of federal regulation fields of GMP,GLP, GXP.
• Biosafetly Level 3 experience/ or high containment facility.

Diversity Statement

•Personal and professional commitment to diversity and inclusion as demonstrated by involvement in teaching, research, creative activity, service to the profession and/or diversity/inclusion activities.

Essential Duties

Job Duty Category Quality Control

• Create/implement/execute written procedures for the evaluation of raw materials, in-process samples and finished product with a high degree of precision and accuracy.
• Perform a variety of simple and complex (bio)-analytical tests using quantitative and qualitative analysis and summarize findings. Examples: Plate-based assays such as ELISAs, total protein by Bradford or BCA, qPCR, pH, appearance, SDS-PAGE with Coomassie staining or Western Blot, or analysis for cytopathic effects.
• Complete sophisticated documentation requirements for all GMP activities following Good Documentation Practices (GDP).
• Support in the creation of controlled documents such as specification sheets, protocols, reports, SOPs and other directive documents.
• Prepare buffers, solvent solutions, and microbial media for scientific use.

Percentage Of Time 60
Essential Duties

Job Duty Category Environmental Monitoring

• Perform environmental monitoring for GMP classified rooms.
• Provide reports regarding the environmental state of all GMP classified rooms.
• Coordinate with cleaning teams to ensure all GMP rooms are maintained a level that satisfies GMP room requirements.

Percentage Of Time 20
Essential Duties

Job Duty Category Administrative

• Required to manage and record non-batch card laboratory activities daily in project-specific laboratory notebooks under GDP.
• Perform other duties as required.

Percentage Of Time 20

Application Details

Special Instructions to Applicants

For full consideration please apply by 1/05/2020, 11:59 p.m. (MT). Please submit a cover letter which addresses the minimum and preferred qualifications, a resume, and the names and contact information for three professional references. References will not be contacted without prior notification of candidates.

Conditions of Employment Pre-employment Criminal Background Check (required for new hires)
Search Contact Cathy Griffin (idrc_jobs@colostate.edu)
EEO Statement

Colorado State University is committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity or expression, or pregnancy and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Colorado State University is an equal opportunity/equal access/affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Colorado State laws, regulations, and executive orders regarding non-discrimination and affirmative action. The Office of Equal Opportunity is located in 101 Student Services.

The Acting Title IX Coordinator is the Assistant Vice President for Student Affairs, 201 Administration Building, Fort Collins, CO. 80523-8004, (970) 491-5312.

The Section 504 and ADA Coordinator is the Associate Vice President for Human Capital, Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836.

Background Check Policy Statement

Colorado State University (CSU) strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks. The type of background check conducted varies by position and can include, but is not limited to, criminal (felony and misdemeanor) history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will be conducted when required by law or contract and when, in the discretion of the university, it is reasonable and prudent to do so.

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